BioSpace, Inc.
Senior Validation Engineer BioSpace
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Senior Validation Engineer
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BioSpace . Get AI-powered advice on this job and more exclusive features. By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role:
As
Senior Validation Engineer , you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How You Will Contribute
Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the assigned role. Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans. Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to the assigned role. Apply advanced theory, technical principles, and expert judgment to address a broad range of problems. Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships. Maintain a state of inspection readiness and act as SME in Health Authority inspections. Approve commissioning documents, including but not limited to commissioning protocols and reports. Evaluate and leverage testing to qualification activities. Generate, execute, and manage detailed project plans and timelines for CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation. Support departmental and capital project validation activities. Provide key performance indicators data at a predetermined frequency. Own change control task of validation activities. Execute validation activities aimed at improving Right First-Time. Present and provide rationale for the completed work during periodic audits and Health Authority inspections. Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation as required per protocols. Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines. Foster an environment that encourages continuous learning and maintain expertise to stay abreast of technical and industry advancements. Support EHS programs and own CAPA records as needed. Accountable for behaviors as described in Takeda Standards, policies, and procedures. What You Bring To Takeda
BS engineering with 8+ years' experience in validation. Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers. Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment; advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities. Familiarity with software development lifecycle (SDLC) and validation tools. Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks. Strong technical and/or engineering knowledge with ability to work collaboratively with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups. Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance. Advanced understanding of data and statistical analysis of validation test results. Basic understanding of data and statistical analysis of validation test results. Knowledge of cGMPs or equivalent regulations, validation-related regulations, guidelines, and best practices. Proficient in Microsoft Word and Excel, and related computer software. Important Considerations
Role At Takeda, our patients rely on us to deliver quality products. In this role, you may: Work in a controlled environment requiring special gowning and protective clothing. Remove all makeup, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary. Work around chemicals that may require respiratory protection. The overall physical exertion is light. Able to work in controlled or clean room environments requiring gowning. May be required to work or be assigned to a different shift as needed. May require availability outside regular business hours. Pace may be fast and job completion demands may be high. More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Locations : USA - CA - Thousand Oaks - Rancho Conejo Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : Yes Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Internet News Referral note: Referrals increase your chances of interviewing at BioSpace. Get notified about new Senior Validation Engineer jobs in Thousand Oaks, CA. #J-18808-Ljbffr
Join to apply for the
Senior Validation Engineer
role at
BioSpace . Get AI-powered advice on this job and more exclusive features. By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role:
As
Senior Validation Engineer , you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How You Will Contribute
Be a Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, systems, utilities, facility, and computerized systems as applicable to the assigned role. Create validation documentation including SOPs, risk assessments, traceability matrices, and validation master plans. Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to the assigned role. Apply advanced theory, technical principles, and expert judgment to address a broad range of problems. Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships. Maintain a state of inspection readiness and act as SME in Health Authority inspections. Approve commissioning documents, including but not limited to commissioning protocols and reports. Evaluate and leverage testing to qualification activities. Generate, execute, and manage detailed project plans and timelines for CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation. Support departmental and capital project validation activities. Provide key performance indicators data at a predetermined frequency. Own change control task of validation activities. Execute validation activities aimed at improving Right First-Time. Present and provide rationale for the completed work during periodic audits and Health Authority inspections. Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation as required per protocols. Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines. Foster an environment that encourages continuous learning and maintain expertise to stay abreast of technical and industry advancements. Support EHS programs and own CAPA records as needed. Accountable for behaviors as described in Takeda Standards, policies, and procedures. What You Bring To Takeda
BS engineering with 8+ years' experience in validation. Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers. Advanced knowledge of equipment, systems, facilities, and utilities in a regulated environment; advanced knowledge of commissioning and qualification of equipment, systems, computerized systems, facility, and utilities. Familiarity with software development lifecycle (SDLC) and validation tools. Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks. Strong technical and/or engineering knowledge with ability to work collaboratively with Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups. Technical expertise to define validation approaches and execute system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance. Advanced understanding of data and statistical analysis of validation test results. Basic understanding of data and statistical analysis of validation test results. Knowledge of cGMPs or equivalent regulations, validation-related regulations, guidelines, and best practices. Proficient in Microsoft Word and Excel, and related computer software. Important Considerations
Role At Takeda, our patients rely on us to deliver quality products. In this role, you may: Work in a controlled environment requiring special gowning and protective clothing. Remove all makeup, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary. Work around chemicals that may require respiratory protection. The overall physical exertion is light. Able to work in controlled or clean room environments requiring gowning. May be required to work or be assigned to a different shift as needed. May require availability outside regular business hours. Pace may be fast and job completion demands may be high. More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Locations : USA - CA - Thousand Oaks - Rancho Conejo Worker Type : Employee Worker Sub-Type : Regular Time Type : Full time Job Exempt : Yes Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries Internet News Referral note: Referrals increase your chances of interviewing at BioSpace. Get notified about new Senior Validation Engineer jobs in Thousand Oaks, CA. #J-18808-Ljbffr